Fosun Pharma's Global Multi-Center Phase III Clinical Trial Project for A New Antimalarial Drug Receives 500 Million Japanese Yen Investment from GHIT Fund to Jointly Improve the Global Accessibility of Antimalarial Drugs

SHANGHAI, Dec. 14, 2023 /PRNewswire/ -- The Japan-based Global Health Innovative Technology Fund (GHIT Fund) announced today that it will invest approximately US$3.3 million (approximately 500 million yen^[1]) in a global multicenter Phase III clinical trial project (the "Program") led by Fosun Pharma for a triple artemisinin combination drug (Artemether-Lumefantrine-Amodiaquine fixed-dose formulation) against malaria in Africa and Southeast Asia, to accelerate the development and commercialization of this new drug.

The Project will be jointly conducted by Fosun Pharma, a major Chinese pharmaceutical and healthcare company, Marubeni, a leading Japanese integrated trading and investment business conglomerate, a Thailand-based research collaboration of universities, Mahidol-Oxford Tropical Medicine Research Unit (MORU), and the product development partnership Medicines for Malaria Venture (MMV), which provides technical support and market access expertise. This is the first time GHIT Fund has invested in a research project led by a Chinese pharmaceutical company.

This drug candidate should have a significant public health benefit as it is expected to play an important role in the fight against artemisinin partial resistance (ART-R) which is now observed widely in the Greater Mekong Subregion (GMS) of Southeast Asia^[2] and to some extent in several African countries, including Rwanda and Uganda. Importantly, the project includes the development of a co-formulated child-friendly version, given that most malaria cases are in children^[3].

Malaria is an infectious parasitic disease transmitted by mosquitos that affects approximately 250 million people annually and was responsible for approximately 620,000 deaths in 2021³. Infection in the African region constitutes 95% of the total global malaria cases, and children under the age of 5 account for 80% of all malaria deaths in this region. The GHIT Fund invests in innovative drug development with the aim of contributing to global health through facilitating collaboration between Japanese and global institutions' technology and innovation to address these neglected infectious diseases.

Wen Deyong, CEO of Fosun Pharma, said, "We are very pleased to work with GHIT Fund to promote the clinical research on this antimalarial innovator drug. The collaboration will accelerate the launch of this new drug so as to actively respond to the threat of artemisinin partial resistance and partner drug resistance of Plasmodium falciparum parasites and save more lives from malaria. Fosun Pharma is committed to further improving the accessibility and affordability of antimalarial drugs through continuous innovation and our global operational capabilities, so as to continuously strive for a malaria-free world."

Dr. Osamu Kunii, CEO of the GHIT Fund, said "We are very excited to have Marubeni and FOSUN PHARMA as our new product development partners. It is an important step forward to invest in the development of antimalarial drugs in late-phase clinical trials to advance commercialization. The number of malaria cases and deaths in children under 5 years old is an urgent issue. This investment will make a significant contribution to reducing the burden of malaria globally, especially among young children."

The antimalarial drug independently developed by Fosun Pharma has been used to treat more than 60 million patients with severe malaria worldwide
The artemisinin based antimalaria medicines originated from China have made significant contributions to global malaria prevention and control.  In Sub-Saharan Africa alone, about 240 million people benefit from artemisinin-based combination therapies every year. The artesunate for injection (Artesun^®) independently developed by Fosun Pharma is the first-line treatment of severe malaria for both adults and children recommended by the WHO since 2011. It has become a well-known Chinese innovator drug in Africa and the world. So far, Artesun® has been used to treat more than 60 million patients with severe malaria worldwide, most of whom were African children under five years old. In June 2023, the second-generation artesunate for injection (Argesun^®) independently developed by Fosun Pharma was prequalified by the WHO (WHO-PQ), becoming the first injectable artesunate presented with a single solvent system approved by WHO-PQ. It greatly improves the convenience of clinical use and is particularly practicable for remote areas in Africa with backward medical conditions to save more lives. Up to now, the product has been registered and marketed in 18 countries.

The deployment of Fosun Pharma's new generation Argesun^® has further improved the accessibility of high-quality antimalarial innovator drugs in Africa, providing a convenient solution for primary medical institutions to treat sever malaria patients and save lives. Fosun Pharma was therefore recognized on Fortune 2023 China's Most Admired Company List.

Effectively reduce the incidence rate of severe malaria in children from treatment to prevention
As an innovation-driven global pharmaceutical and health industry group, Fosun Pharma has independently developed innovative antimalarial products covering malaria prevention and treatment, as well as the rescue of critically ill patients. From "treatment" to "prevention", Fosun Pharma continues to provide more prevention and treatment solutions for malaria patients, especially children.

In August 2018, Fosun Pharma's SPAQ-CO^® Disp (co-packed sulfadoxine-pyrimethamine dispersible tablets and amodiaquine dispersible tablets), for the prevention of malaria in children, was prequalified by WHO. Fosun Pharma has actively carried out community-oriented "Child Malaria Prevention Knowledge Popularization Projects" in 14 malaria-endemic countries in Africa. These projects aim to enhance local awareness of malaria prevention among African populations, thus helping to reduce the incidence of malaria and interrupt community transmission of the disease. By the end of June 2023, more than 245 million children in Africa had benefited from the "Seasonal Malaria Chemoprevention Program", for which SPAQ-CO^® Disp is used as the core drug, effectively reducing the incidence of malaria in children under five years old in Africa.

About GHIT Fund
The GHIT Fund is a Japan-based international public-private partnership (PPP)  fund that was formed between the Government of Japan, multiple pharmaceutical companies, the Bill & Melinda Gates Foundation, Wellcome, and the United Nations Development Programme (UNDP). The GHIT Fund invests in and manages an R&D portfolio of development partnerships aimed at addressing neglected diseases, such as malaria, tuberculosis, and neglected tropical diseases, which afflict the world's vulnerable and underserved populations. In collaboration with global partners, the GHIT Fund mobilizes Japanese industry, academia, and research institutes to create new drugs, vaccines, and diagnostics for malaria, tuberculosis, and neglected tropical diseases. https://www.ghitfund.org/en

About Fosun Pharma
Founded in 1994, Shanghai Fosun Pharmaceutical (Group) Co., Ltd.* ("Fosun Pharma"; stock code: 600196. SH, 02196. HK) is a global innovation-driven pharmaceutical and healthcare industry group. Fosun Pharma directly operates businesses including pharmaceuticals, medical devices, medical diagnosis, and healthcare services. As a shareholder of Sinopharm Co., Ltd., Fosun Pharma expands its areas in the pharmaceutical distribution and retail business.

Fosun Pharma is patient-centered and clinical needs-oriented. The company continuously enriches its innovative product pipeline through independent research and development, cooperative development, license-in, and in-depth incubation. Fosun Pharma improves the research and clinical development capabilities of FIC (First-in-class) and BIC (Best-in-class) new drugs as well as accelerates the R&D and launch of innovative technologies and products.

Guided by the 4IN strategy (Innovation, Internationalization, Intelligentization, and Integration), Fosun Pharma will uphold the development model of "Innovation Transformation, Integrated Operation and Steady Growth", with the mission of creating shareholder values through strengthening its independent R&D and external cooperation and enriching its product pipelines, as well as promoting the global networks and enhancing operational efficiency. Fosun Pharma will actively promote the digital and physical business layout in the pharmaceutical and healthcare industry and is committed to becoming a first-class enterprise in the global pharmaceutical and healthcare markets.

For more information, please visit our official website: www.fosunpharma.com.

SOURCE Fosun Pharma